A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

basiliximab

Intervention Type DRUG

2 intravenous doses

efalizumab

Intervention Type DRUG

Subcutaneous repeating dose

mycophenolate mofetil

Intervention Type DRUG

Oral repeating dose

corticosteroids

Intervention Type DRUG

Repeating doses

2

Group Type ACTIVE_COMPARATOR

basiliximab

Intervention Type DRUG

2 intravenous doses

mycophenolate mofetil

Intervention Type DRUG

Oral repeating dose

corticosteroids

Intervention Type DRUG

Repeating doses

cyclosporine

Intervention Type DRUG

Oral repeating dose

Interventions

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basiliximab

2 intravenous doses

Intervention Type DRUG

efalizumab

Subcutaneous repeating dose

Intervention Type DRUG

mycophenolate mofetil

Oral repeating dose

Intervention Type DRUG

corticosteroids

Repeating doses

Intervention Type DRUG

cyclosporine

Oral repeating dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have signed the informed consent form and the HIPAA patient information form (United States only)
* Are ≥ 18 years of age
* Are a transplant recipient of at least one HLA-mismatch kidney
* For subjects of reproductive potential (men and women), are willing to use effective contraception, unless abstinence is the chosen method

Exclusion Criteria

* Have a history of previous renal transplant
* Have had a PRA \> 25% at any time
* Have a history of or evidence of cancer except for basal cell carcinoma that has been excised and cervical carcinoma in situ
* Have a positive T-cell lymphocytotoxic crossmatch with the use of donor lymphocytes and recipient serum
* Have had previous treatment with efalizumab
* Have used any investigational drug within 28 days or 5 half-lives of screening, whichever is longer
* Have a known contraindication to efalizumab
* Have a history of severe allergic or anaphylactic reactions to monoclonal antibodies
* Have had a known allergic reaction or intolerance to any of the following medications: CsA; MMF; Corticosteroids; Basiliximab
* Are allergic to iodinated contrast media that would preclude GFR measurement with iothalamate

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No